1. Field of Invention
This invention relates to methods and compositions for the irradication and treatment of diaper rash and related microbe-compounded diaper dermatitis.
2. Description of Prior Art
Diaper dermatitis, commonly referred to as diaper rash, is a form of irritation and inflammation that occurs in the area covered by a diaper. Although it is often dismissed by mothers or physicians as a minor problem, diaper dermatitis can have serious secondary sequela. If left untreated, diaper dermatitis can cause masceration of the skin leading to infections, trauma, and systemic disease.
"The only children who never have diaper dermatitis are those who never wear diapers" (Mantel et.al.,1980). This extremely common skin disorder is not only one of the most prevalent among infants and young children, but one of the most irritating, painful, and troublesome conditions facing babies and their mothers.
The precise prevalence of infants who suffer from diaper dermatitis is unknown. Several studies (Leyden, 1986) estimate that approximately 10% of infants between the ages of 0 to 2 years will develop diaper dermatitis although this is considered a gross underestimation. The peak incidence occurs in the 7 to 9 month age group. The U.S. Department of Health and Human Services has indicated that diaper dermatitis itself accounted for 97 visits to a physician for every 1000 infants in the United States between the ages of 0 to 2 years of age (DHHS, 1978). As most cases of diaper dermatitis are treated with over-the-counter (OTC) products, this statistic most likely reflects only the most severe cases which required more vigorous treatment.
Other data demonstrate that infants being treated for otitis media (ear infections) with antibiotics (e.g. Amoxicillin) were found to be at higher risk for diaper dermatitis compounded by a fungal infection such as Candida albicans (Honig et.al., 1988). Although infants who were breastfed had a lower prevalence and severity of diaper dermatitis (Benjamin, 1987; Berg, 1987), many infants and young children are not breastfed for long periods of time and/or are placed on supplemental oral feedings.
It is generally accepted that true diaper rash begins as a contact irritant dermatitis. The irritation from simple diaper dermatitis results from constant exposure of weakened or immature skin to urine or feces or both. The most commonly accepted list of factors linked to diaper dermatitis include ammonia, bacteria, the bi-products of bacterial action, urine pH, Candida albicans and moisture (Berg, 1987). In addition, the use of commercially available perineal cleansing wipes that contain alcohol and/or fragrances only serve to further irritate already exposed and compromised skin tissue.
Attempts to irradicate diaper dermatitis have heretofore been exclusively directed toward counteracting suspected causes of dermatitis by utilizing compositions which:
1. Promote dryness; or, PA1 2. Provide barriers in the forms of zinc oxide, petrolatum-based substances, and lipase-inhibiting agents such as zinc chloride; or, PA1 3. contain anti-inflammatory steroidal preparations. PA1 1. are only effective when used in the prevention of diaper dermatitis, not the treatment; PA1 2. are of little value once the infant's skin has broken down and diaper dermatitis is evidenced; PA1 3. are ineffective in combating a diaper dermatitis which is compounded by the presences of bacteria and/or fungus; PA1 4. are frequently dispensed in multi-dose, reusable containers which render the product subject to contamination and could potentially worsen an existing case of diaper dermatitis; and, PA1 5. are rarely used in conjunction with an effective cleansing methodology. In fact, it is extremely difficult to cleanse the infant's skin once these products have been applied. PA1 1. to provide a composition which is effective in the treatment of diaper dermatitis as demonstrated in a relevant clinical study (to be discussed later in this application); PA1 2. to provide a composition which is effective as, but not limited solely to, a barrier against common irritants; PA1 3. to provide a composition which is effective as, but not limited solely to, a skin conditioning agent; PA1 4. to provide a composition which is effective in the treatment of diaper dermatitis which is complicated by bacteria and or yeast infections; PA1 5. to provide a method for more effective treatment of diaper dermatitis which includes proper cleansing with a specific type of cleansing agent followed by the application of an effective composition; and, PA1 6. to provide a method for dispensing said compound in such a manner as to eliminate the potential for product contamination.
Up until the present time, the treatments used for the alleviation of diaper dermatitis have focused almost exclusively on providing a barrier against common irritants. The action of these commonly used preparations is to protect the infant's sensitive skin from deterioration. Unfortunately, these preparations do little to nothing to stop the further breakdown of the skin once a full blown case of diaper dermatitis is evidenced. In fact, many pediatricians have observed that once a case of diaper dermatitis has begun, the use of air occlusive (e.g. barrier types) ointments and creams hinders the healing process (Mantel et.al.,1980).
One example of a popular OTC diaper dermatitis treatment which employs a barrier method is Desitin.RTM. ointment, a product of Pfizer, Inc. It contains two of the common barrier substances (zinc oxide and petrolatum) and additionally contains two common skin conditioning agents (cod liver oil and lanolin). In a recent study (to be described in detail later in this document), Desitin.RTM. ointment was utilized as one of the treatments under study and found statistically inferior to other products.
Recent research indicates that there is a significant correlation between the existence of bacteria and yeast in an infant's perineal area and the presence of diaper dermatitis. The upsurge in physician use of antibiotics to treat infants with ear infections has been linked to a new variety of diaper dermatitis that is compounded by bacteria and yeast (fungus). Thus, the use of currently available barrier methods in reusable tubes and/or containers is no longer effective in treating the vast majority of diaper dermatitis occurrences and could possibly worsen a dermatitis because they inhibit the healing process and subject the baby to repeated exposure to a contaminated product. In addition, the use of barrier method agents that are packaged in reusable containers makes transport of offending microbes from one infant to another a likely possibility.
It is apparent from the above discussion that diaper dermatitis can be a very troublesome ailment for the infant and young child. While there are over-the-counter products available that purport to be effective in the treatment of diaper dermatitis, most of these products are considered ineffective because they